Aspivix has announced that its Carevix device has received approval from the Medicines & Healthcare products Regulatory Agency (MHRA) for use in the United Kingdom. Aspivix says this milestone marks a pivotal moment for the company and underscores its commitment to ‘modernising gynecology’ under its mission, ‘Gynecology. Now Modern.’
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The company says that Carevix is designed to ‘redefine the standards’ of care in gynecology, offering a more comfortable and empowering experience for patients and healthcare providers alike for transcervical procedures in gynecology, oncology and fertility, including IUD/coil insertions.
“Receiving MHRA approval is not just an achievement for Aspivix but a victory for women’s healthcare globally,” said Mathieu Horras, CEO & Co-Founder of Aspivix. “This endorsement allows us to bring Carevix to the UK market, further expanding our reach and impact on women’s health. With existing FDA approval for the US and CE Mark for Europe, we are poised to make significant advancements in gynecological care.”
By focusing on minimally invasive, patient-centric solutions, Aspivix says it aims to ensure a positive experience for all women by alleviating the pain and bleeding associated with gynecological transcervical procedures such as coil fitting, hysteroscopies, endometrial biopsies.
Women are offered the opportunity to benefit from Carevix at the Peterborough City Hospital – North West Anglia NHS Foundation Trust.
“Carevix looks like an excellent product and our team at Peterborough City Hospital is very happy to join the program. I’m sure the patients would love it,” said Dr. Lukasz Polanski, an esteemed member of the Royal College of Obstetricians and Gynaecologists.
Peterborough City Hospital becomes the 17th center of excellence joining the Carevix Ambassador Program which allows OB-GYNs, midwives and nurses worldwide (US, Brazil, France, Sweden, Switzerland, Germany, Italy) using Carevix in routine gynecological procedures.
Aspivix says over 600 patients have benefitted from the use of the Carevix worldwide as part of the Ambassador Program using Carevix in routine.
